Monarc® Subfascial Hammock

Overview

The Monarc Subfascial Hammock is a minimally invasive treatment option for female patients suffering from stress urinary incontinence (SUI). Monarc's transobturator approach and proven, Type 1 polypropylene mesh create a hammock-shaped midurethral sling that treats SUI by supporting the urethra during times of increased abdominal pressure, such as sneezing, coughing or laughing. Monarc's efficacy has been proven in multiple clinical trials and its outside-to-in transobturator approach avoids the retropubic space, reducing the potential for serious complications.

Features and Benefits

The Needle

The Monarc Subfascial Hammock is a single-use procedure kit that includes two stainless steel needles each specifically designed for right-side/left-side. The needles are designed to move away from the obturator canal, avoid the retropubic space and minimize blind needle passage.

The Monarc TOS series allows consultants to select from three needle types to better accommodate individual patient anatomy:

  • Standard Monarc — Tight, centered helical passer for small to medium or large patients
  • Monarc+ — Wide, centered helical passer for larger patients
  • Monarc C — Passer for consultants who prefer the C shape

Monarc Needle

For a complete list of warnings and precautions please review Safety Information.

The Mesh

Monarc's proven Type 1 polypropylene mesh offers tissue fixation without suturing and large pores to facilitate tissue integration. The patented tensioning suture maintains mesh integrity during placement and allows for intra and immediate post-operative tensioning while reducing sling deformation.

Benefits

The Monarc procedure uses an innovative transobturator approach that avoids the retropubic space and creates a restorative hammock that mimicks the patient's natural anatomy. With a transobturator approach, cystoscopy can be performed at the consultant's discretion.

The Monarc procedure offers many benefits:

  • Proven efficacy and safety
  • Minimally invasive, quick procedure performed in under 15 minutes
  • Incision sites in the vagina and femoral/pelvic fold are small
  • Appropriate for patients who have retropubic scarring
  • Outside-to-in approach moves needles away from dangerous vessels and nerves
  • Needles are designed to facilitate accurate needle placement and minimize blind needle pass
  • Mesh is attached to the needle passers with secure locking connectors
  • Resorbable tensioning suture maintains mesh and enables fine adjustments in mesh tension during the procedure and in the immediate postoperative period
  • Can be used with local, spinal or general anesthesida

After the procedure, most patients experience immediate continence.

Placement & Function

The Monarc Subfascial Hammock prevents undesired leakage by restoring support to the urethra. The hammock shaped sling acts as a backboard for the urethra, just like normal urethra tissue does when abdominal pressure occurs.

The Monarc self-fixating mesh is anchored to the obturator membrane and muscle with a lateral, transobturator approach, which forms a hammock-shaped urethral support. The open V-shape of the hammock mimics pubourethral ligaments and pubocervical fascia and is placed beneath the midurethra along the same plane as the endopelvic fascia.

Procedure

The Monarc Subfascial Hammock is a minimally invasive procedure that lasts about 20 minutes. Click here for a brief summary of the surgical procedure.

Caution: This information is for educational purposes only. See the Instructions for Use document and videos for more detailed instructions on this surgical procedure.

Click here to view step-by-step instructions for Monarc.

Post-Surgical Care

Oral antibiotics and analgesics can be administered at the consultant's discretion.

The patient should abstain from heavy lifting, exercise and sexual intercourse for a minimum of four weeks. Patients can return to other normal activities, often two to four weeks post surgery.

If the patient is considering pregnancy, she should be counseled that future pregnancies may negate the effects of the surgical procedure.

The patient should be instructed to call the consultant immediately if dysuria, bleeding, prolonged pain or other problems occur.

Results

Perioperative Complications and Adverse Events of the Monarc Transobturator Tape, Compared with the Tension-Free Vaginal Tape
Barber MD, Gustilo-Ashby AM, Chen CCG, Kaplan P, Paraiso MFR, Walters MD. Am J Obstet Gynecol 2006 epub.
The study found the Monarc TOT is a safe procedure that may have a lower complication rate than the TVT, particularly with regard to bladder injuries and postoperative voiding dysfunction.
Click here to view the PubMed abstract.

Prospective Multicentre Trial of Monarc Transobturator Sling for stress Incontinence: 24 Month Functional Data
Deridder D, Jacquetin B, Fischer A, Debodinance P, Marques Queimadelos A, Courtieu C, Cervigni M, rassler J, Rane A, Herschorn S, Urwin G, Goetze, Ouellet S, Schrader M, Mellier G Eur Urol Apr 2006;5(2 suppl.): 267 abstract 978. 21st Annual Congress of the European Association of Urology
Twenty-four month data show that Monarc transobturator sling successfully restores continence in women with SUI. Patient and consultant assessed continence rate (completely dry and substantially continent) were both 82%. UDI-6 and HQ-7 were significantly improved from baseline. Given the 11.5% of patients with de novo urge and the 27.9% of patients who were cured of their pre-operative urge, patients implanted with Monarc are significantly more likely to be cured of urge symptoms than to develop urge symptoms (p < 0.005).
** Journal on file at AMS

An Anatomical Study of the Obturator Foramen and Dorsal Nerve of the Clitoris and their Relationship to Minimally Invasive Slings
Achtari C, Mckenzie BJ, Hiscock R, Rosamilia A, Schierlitz L, Briggs CA, Dwyer PL. Int Urogynecol J Jun 2006;17(4):330-4.
This study found significant differences between the TVT-O and Monarc transobturator devices and their proximity to the obturator canal on average, the Monarc was located 0.8 cm further away from the obturator canal than TVT-O. There was no significant difference to the DNC, with Monarc possibly being the safest given its outside-in course.
Click here to view the PubMed abstract.

TVT vs Monarc: A Comparative Study
Dietz H P, Barry C, Lim Y, Rane A. Int Urogynecol J. Pelvic Floor Dysfunct Nov 2006;17(6):566-9
This comparative study of 114 women after Monarc and TVT surgery demonstrated that the mode of action of transobturator tapes seems to be largely identical to that of TVT-type slings. However, the Monarc tape seems to have less effect on voiding and is associated with less postoperative urge incontinence. Possibly as a consequence, the transobturator tape was associated with higher patient satisfaction and subjective overall cure/improvement at approximately 9 months follow-up.
Click here to view the PubMed abstract.

Transobturator Versus Transabdominal Mid Urethral Slings: A Multi-Institutional Comparison of Obstructive Voiding Complications
More AF, Medendorp AR, Noller MW, Mora RV, Shandera KC*, Foley JP, Rivera LR, Reyna JA, Terry PJ. J Urol Mar 2006;174:1014-1017
Although transobturator and transabdominal sling procedures had similar short-term results for decreasing pad use in patients with stress urinary incontinence, the transobturator approach is associated with fewer obstructive voiding complications.
Click here to view the PubMed abstract.
* AMS employee

Multicenter Experience with the Monarc Transobturator Sling System to Treat Stress Urinary Incontinence
Davila GW, Johnson JD, Serels S. Int Urogynecol J Sep 2006;17(5):460-465
Monarc transobturator slings are 95.3% effective for surgical treatment of SUI at 6 months and may offer increased safety relative to traditional or tension-free retropubic slings.
Funding for data collection was provided by American Medical Systems.
Click here to view the PubMed abstract.

In Vivo Comparison of Suburethral Sling Materials
Slack M, Sandhu JS, Staskin DR, Grant RC*. Int Urogynecol J 2006;17:106-110.
In vivo tissue responses were compared for three commercially available polypropylene suburethral slings that differ markedly in fabric structure and in size of resulting interstices and pores. All three elicited the same basic inflammatory response; however, individual fabric structures produced distinct differences in tissue formation within each mesh. The presence of numerous, closely spaced, small diameter filaments prevented formation of extensive fibrous connective tissue within two slings (ObTapeTM and IVS Tunneller mesh). The much larger diameter monofilament and open knit structure of the Monarc® sling permitted the most extensive fibrous tissue integration.
Click here to view the PubMed abstract.
* AMS employee

Patient Selection

The Monarc Subfascial Hammock is indicated for patients with hypermobility and intrinsic sphincteric deficiency (ISD).

Monarc is not recommended for those who are pregnant or have:

  • Overflow incontinence
  • Blood coagulation disorders
  • Compromised immune systems
  • Untreated vaginal or urinary tract infections
  • A history of synthetic graft rejection
  • Future pregnancy plans

For a complete list, see the Instructions for Use document.

Safety Information